{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Medical X- Ray Imaging Devices Conformance with IEC Standards.\" This guidance describes FDA's policy regarding the regulation of medical x-ray imaging equipment that is subject to the Federal Food, Drug and Cosmetic Act (FD&C Act) and FDA's regulations that apply to medical devices and electronic products.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2019/05/08/2019-09405.html","cfr_references":[],"citation":"84 FR 20145","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on May 8, 2019.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-D-2049"],"dockets":[],"document_number":"2019-09405","effective_on":null,"end_page":20146,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2019/05/08/2019-09405.xml","html_url":"https://www.federalregister.gov/documents/2019/05/08/2019-09405/medical-x-ray-imaging-devices-conformance-with-international-electrotechnical-commission-standards","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2019-09405?publication_date=2019-05-08","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2019-05-08/2019-09405/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":470,"last_updated":"2026-10-24 20:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2019-05-08/pdf/2019-09405.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-09405.pdf?1557233119","publication_date":"2019-05-08","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2019/05/08/2019-09405.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2019-05-24T16:51:05Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":20145,"subtype":null,"title":"Medical X-Ray Imaging Devices Conformance With International Electrotechnical Commission Standards; Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Medical X-Ray Imaging Devices Conformance with International Electrotechnical Commission Standards","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":84}